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09 October 2007

What the FDA wants your vet to tell you

The FDA has prepared a brochure for veterinarians to give to their clients who are prescribed NSAIDs for their dogs. Approved NSAIDs in the United States include:

ETOGESIC (etodolac)

RIMADYL (carprofen)

METACAM (meloxicam)

DERAMAXX (deracoxib)

PREVICOX (firocoxib)

ZUBRIN (tepoxalin)

NOVOX (carprofen)

(Although available without a prescription, it's important to note that aspirin is also in this class of drugs.)

The brochure is actually very accurate and stresses both the benefits of these drugs, primarly in relieving the pain of osteoarthritis in dogs as well as post-surgical pain, and the risks, which can be substantial and include death.

I'm all about the pain relief and have given several different NSAIDS to my dogs. I'm not one of the people you'll meet on the Internets who thinks they're evil and shouldn't ever be used.

I do feel NSAIDs, like all medications, should be used only when necessary, properly, and with a full understanding of what signs to watch out for in case there is a problem. This brochure does an excellent job of pinpointing the warnings signs of what can be life-threatening side effects, including:

Behavior Changes

Eating Less

Skin Redness, Scabs

Tarry Stool/Diarrhea/Vomiting

Those symptoms, they say, mean you should stop giving the drug immediately, and contact your vet -- advice that can be lifesaving. The brochure also clarifies that more than one NSAID cannot be given at a time, and specifically warns against aspirin, something most pet owners do not realize is dangerous to give with other NSAIDs. It also mentions that corticosteroids cannot be given with NSAIDs, but I wish they'd mentioned that includes prednisone and prednisolone.

The brochure also gives information on what to discuss with your vet before giving the drug to your dog, including one on pre-drug testing that could save your dog's life. The FDA tells you to ask your vet:

what the NSAID is being prescribed for

how much to give

how long to give it

possible side effects

what to avoid while your dog is taking an NSAID

what tests are needed before giving an NSAID to your dog

how often should your dog be re-examined

your dog’s previous medical history and any previous drug reactions

all medications and products your dog currently receives

If more clients understood how to properly use NSAIDs, a lot of the genuine bad outcomes and not-so-genuine urban legends that get passed around might be cut in half. More importantly, many dogs who were harmed and even killed by avoidable side effects and adverse reactions would have been saved.

Unfortunately, almost no clients I know have ever been given even the most basic of warnings about these drugs by their vets, let alone the client information sheet that the FDA requires be handed out with each prescription. (I should mention that many vets do follow this requirement; my dogs' surgeon, Dr. Gary Brown of Fremont, CA, handed it out to me every time he filled my dog Raven's NSAID prescription when she had bone cancer, and went over it with me carefully.)

Nor are most clients offered safer alternatives to try first, such as acupuncture, supplements, chiropractic, physical therapy, the human drug Tramadol, or even the prescription veterinary drug Adequan Canine, an injectable joint treatment that selectively targets inflamed joints and actually helps rebuild cartilage -- unlike NSAIDs, which tend to mask pain and degrade cartilage in the joints. While it doesn't help every dog, I've had several get great benefit from it, and never progress to needing NSAIDs even in old age.

In addition, few vets routinely recommend the use of stomach-protecting drugs such as misoprostol and sucralfate when they prescribe NSAIDs. They instead often wait until the dog has problems to suggest gastrointestinal protection, and even then, it's frequently some kind of antacid, which is the least effective therapy for the damage caused by NSAIDs. In fact, while antacids sometimes makes dogs feel better, they actually have no protective or therapeutic benefit at all, unlike the other two drugs.

NSAIDs have a place, a big place, in veterinary medicine. I've used them for my dogs, and I'll use them again. I take them myself from time to time, and I wouldn't have gotten through a back injury without them. But they're often used when there are safer alternatives, albeit ones without a big marketing budget from the drug companies behind them. If drug sales reps aren't calling at your vet's office reminding them about human drugs like Tramadol, misoprostol, and sucralfate, nor even veterinary drugs like Adequan Canine, it's all too easy for a veterinarian to reach for an NSAID every time a dog needs some pain relief.

If nothing else, it would be nice to see them reach for this brochure, too, and make sure their clients know everything they need to know to use these drugs safely and correctly.

Check out -- better yet, print out -- a PDF file of the brochure here. There's a text version here, as well.

Gina and I have had some hard words in the past for the FDA's handling of the pet food recall, but if pet owners are still unaware of the potential problems with NSAIDs and how to avoid them, it's not because the FDA isn't trying to get the word out to your dog's veterinarian. Make sure your vet passes that information on to you.

Comments

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Actually, it says there are no oral NSAIDs approved for use in cats, but there are other drugs that are.

And that said, some NSAIDs are used in cats despite the lack of an approved drug. Because felines can have some challenging physiological reactions to certain medications, it's best to discuss this with a veterinarian who is board-certified in feline practice. They will be able to guide you to a pain management protocol that will be safe for your cat. The "NSAID as panacea" problem appears to be almost entirely aimed at dogs at this point, rather than cats, probably because cats suffer less from arthritis (although they do get it).

Having lost my 8 year old bully girl from carprofen toxicity, I strongly urge anyone contemplating using any NSAID's to be certain about the side effects. Talk with your vet. My girl was on a therapeutic dose of carprofen for mild arthritic symptoms, which helped, but killed the dog. My vet said nothing about prior testing, risks, or anything. I know there are always risks to medication, but did not realize this was so acutely toxic. There were no outward symptoms for a couple weeks, then a UTI, then jaundice, and emergency trip to UCD, she died in ICU. Do not consider taking any medication as risk free, be cautious.

"Administer a single, one-time subcutaneous dose of Metacam 5 mg/mL Solution for Injection to cats at a dose of 0.14 mg/lb (0.3 mg/kg) body weight. Use of additional meloxicam or other NSAIDs is contraindicated.

[...}Do not administer a second dose of meloxicam. Do not follow meloxicam dose with any other NSAID." (Emphasis theirs)

There are regulations that allow off-label use of drugs, especially intended to allow effective pain relief. Some drugs are allowed, some forbidden, most may be used according to the vet's clinical judgement. However it is always important to be informed as to his or her reasons and the risks. If a vet ever suggests a drug is without risk, this is a warning sign.

I know a lot of people who ask their vet to prescribe the human drug Tramadol in lieu of a veterinary NSAID, and the vets are all OMG no, that's not licensed for dogs and cats!

And I laugh. Because neither are ANY chemo drugs, morphine, Fentanyl, almost every single antibiotic and steroid vets use and prescribe every day, and so many more I can't even count them. Vets use "human" drugs and do off-label prescribing all day every day.

I certainly don't think a vet should just prescribe something because you ask for it, or if they don't know anything about it. But the solution to that is to LEARN SOMETHING ABOUT IT, not to just say no.

The Veterinary Information Network is available to vets. If they don't want to pay to join that, they can look at the website of VIN's anesthesia/analgesia consultants, vasg.org, which is FREE and open to all. Or they can crack open a copy of Plumb's Veterinary Drug Handbook, the PDR of veterinary medicine, which will tell them everything they need to know to prescribe every "human" drug I've mentioned safely for dogs and cats.

I've been using Rimadyl on my dogs since it first became available. each and every vet that suggested it always required prior testing and warned me of the possible side effects. This probably includes at least 6 vets in 3 different practices. And then there's always the product insert and the internet.

Why would anyone give a drug to their animal that they knew nothing about?

Why would you go to a vet who didn't give you written informaiton about every drug they prescribed?

Why would you go to a vet who didn’t give you written informaiton about every drug they prescribed?

I wouldn't, and yet your experience is simply not common. Not at all. I know this not just from talking to hundreds, make that thousands, of pet owners in the course of my job, but the many veterinarians I have worked with, too. Some share your view, and are appalled at how their colleagues are not living up to these professional standards (and legal requirements), and others, like you also point the finger at pet owners who aren't demanding this information from their vets.

Veterinary drugs are dispensed as at a human pharmacy, in the practice's own packaging in most cases, or with a practice label slapped over the manufacturer's label if you are buying an entire container. And yet, there is no pharmacist. Most of these drugs are handed over by the receptionist with only the information they've hand-written or printed on the practice's label. There might be some pre-printed cautions about not sharing the drugs with other pets or keeping away from children, but all those carefully worded package inserts, label disclaimers, and CIS? The vast majority of clients never see those, or even think to ask for them, and the vets certainly never offer them.

Would I go to a vet like that? No. Obviously neither do you. But most people do.

When I pick up MY asthma drugs each and every month, they come not only with the package inserts but also with a print-out from the pharmacy with all the warnings, side-effects, contraindications, blah-de-blah-blah-blah. And I must SIGN in acknowledgement that I got those handouts, and that I will pretend I have read them.

Whenever I have a NEW drug -- not a refill -- the pharmacist goes over it with me personally.

Of course, much of this is law, and some of it is CYA for the pharmacy.

But why should at least some of these steps not be taken with pet meds? (Especially since -- as we've previously discussed -- many are "human" drugs used off-label for pets.)

When I fill a prescription for my dogs at the pharmacy, the pharmacist goes over it with me just as if it were a human drug.

Where the sloppiness comes in, IMO, is the evolution of veterinary medicine to allow veterinarians to act as dispensing pharmacists. Technically they can do this only for their own patients and they are subject to their state's and any federal pharmacy laws. And yet, few veterinarians that I know even know what the pharmacy laws ARE. They cheerfully dispense meds to other vet's clients if the vet calls them, even though, at least in CA, this is illegal. They don't go over the warnings, package inserts, etc., and few of them even hand out CIS.

A doctor would not be allowed by law to run a pharmacy out of his office, but nearly all vets do. It's a big gray area and IMO it's problematic. Is it convenient for clients? Yes. Has it become an established part of the income stream for veterinary practices? Yes. Would changing it now that it's become established hurt those practices? Yes. Does it carry a lot of risks? Yes. Is it ethically murky? Yes.

The problem is the way the profession evolved, to the point where clients pay for everything BUT the fair market rate for the professional expertise of a good veterinarian.

I remember when veterinarians (or at least the one our family used when I was growing up) didn't even charge for an annual exam -- it was free with "yearly shots."

So we end up with a situation where income is generated on retail -- pharmacy, food and even pet accessories in some practices -- instead of on medicine. Not an ideal situation for a health-care professional, on either side of the examination table. (There's a reason doctors send patients out for Rx and diagnostics -- the potential for conflict of interest is real.)

Perhaps with a wider realization by pet-lovers that "yearly shots" are no longer recommended -- but annual or even semi-annual examinations with diagnostics (especially for older pets) ARE, there may be a shift over time in the way veterinary practices are run.

Regarding research: There is a National Dog Genome Project in which pedigree dogs' genomes are being studied. Owners can participate; you're sent containers to hold the dog's blood that is drawn by a vet. They have a need for certain breeds. Unfortunately they do not pay for the vet visit to get the blood. Here's the link for more info.

My 8 year old dog shelby,had bloodword done on jan,7,08,then had a marble sized lump removed from his groin area,in which both came back 100 percent perfect,he did not look well when i picked him up,got him home he had problems walking on hind leg,quit eating and drinking,i phoned the vet,they did not seem to really care,I then noticed weight loss,the runs,not sleeping,eating,had my records transfered,got second opinion,vet number 2 did not understand it,because blood was great,from 1st vet,that night my dog passed away,I then did reserch on the drug metacam,and my dog had all of the side effects,so my family and i lost our pet we had for 9 years,because she gave him this drug during surgery,she did not get my consent,did not tell me she was giving this to him,and did not do any tests on him before or after surgery,administering this drug without my consent killed my dog.it was like losing a child.I had soon after reported this vet to the college of vets, because It was just wrong,it has devistated my entire family terribly.

My 14 year old cocker spanial suffered recurring staff infection over a year.I repeatedly asked the vetenary staff if the frontlin or advantage could be linked and was always told it was the flee alergy. She started having flee alergies after begining the flee repelent tx.Finally aftter stopping the meds for 3 months my sweet heart is well.

I took my kitty to a "holistic" vet in my neighborhood around the same time that that vet was profiled on CBS Sunday morning for her "forward-thinking" approach. My kitty, a new rescue, had had chronic diarrhea for 9 months. Our mainstream vet had prescribed prednisolone, without any warnings about the risks of steroids.

I looked it up on the Internet myself *before* giving it to her and chose not to administer and get a second opinion instead.

First, the holistic vet gave me a lecture on "food allergies," (which I later learned meant "I don't know squat about what's wrong with your cat"). Two days later, she had the receptionist call me to pick up a prescription for Panicur. The vet had said nothing about this to me, and I had to ask the receptionist what it was and why it was being prescribed. The receptionist conveyed my question back to the vet, and then the vet had the *receptionist* call me back to tell me! This ticked me off.

When this so-called "holistic" vet did the same routine with a prescription for Albon -- with all communication coming and going through the receptionist -- I lost all confidence in the vet. I was furious. I booked another appointment with the vet just so I could TALK to her.

In the meantime, I had done a great deal of research on raw feeding for cats and wanted to give it a try. So I asked the "holistic" vet what she thought. She told me to hold off while we tried some other things first. Since her idea of trying other things was to give drugs without an explanation, and since the baby food she had me feed my kitty this whole time only made kitty's poo into pudding, I said, "Eff it," and tried the raw diet anyway.

Kitty was CURED within 10 days on raw diet. This whole experience really turned me onto the sloppiness of veterinary practice, and these were vets with active practices in a major US city.

I'm just glad that it is MY habit that I do not put ANYTHING into my kitties without first researching it thoroughly on the net AND asking the vet questions about it. Fortunately my pets have never been in such an urgent condition that the delay in administering meds has not been an issue.

Hmm better rethink that Adequan shot as safe - it can be an issue in diabetic animals as can glucosamine.

Nothing is safe when it comes to meds.

Those 'supplements' may not even contain anything listed on the label or have the items in completely different amounts than listed.

The more you know about your own meds or your animal's meds the safer you all may be.

No one cares as much about your health or your animals' health as you do. Being an informed consumer is YOUR job not the job of the person selling you something even if the law tries to make it be their job.

"Being an informed consumer is YOUR job not the job of the person selling you something even if the law tries to make it be their job."

Sure Nancy but I rely on professionals in various fields to help me when I seek their services. It's reasonable to expect that my Vet will give me proper information and guidance just as I expect my plumber to do the same.

Our Dog Cameron was given Zubrin for his arthritis and because of all the side effects for which the vet never talked to us about, he developed bloody diarrhea, confusion, depression, not eating, not drinking, and when we took him to the vet, his white blood count was unusually high. Probably because he was in so much pain. We had to put him down. I couldn't see him suffering anymore. He was only on the drug a little less than a month. The vet did not tell us to stop the drug if any of these symptoms occurred. I stopped the drug when it was too late. He died 4/07/2008. He will be missed very much. DO NOT PUT ANY DOG ON ANY NSAIDS INCLUDING ZUBRIN. IT IS TOXIC TO DOGS AND CATS. WARNING WARNING WARNING

I'm extremely sorry for your loss. I'm sorry that your vet did not properly inform you of the risks, the side effects, or what to do if he had any of them. All those things are tragic and unfortunate, and my heart aches for you.

But telling people not to use NSAIDs for their dogs when pain itself causes people to euthanize their pets, causes suffering, is an over-reaction born from understandable grief. Properly used, these medications can extend life and improve quality of life enormously.

After suffering with side effects from medicines given to me at various times, I question any drug given to me or my pets.

For a long time I have felt that it is up to me to research the facts after my doctor or my veterinarian tell me what to do. It is my health and my cats' that is involved.

As to human drugs for cats, in New England I was given a human eye medicine for my cat. Unfortunately it was not prescribed here in Colorado. But I did get some feline medicine which cured her eye, anyway.

It was very frustrating not being able to get the human medicine--but he is a very caring and careful veterinarian so I am grateful for that.

My sweet English bulldog had patella surgery at 6 months old and is now 3. The pin in her leg was recently discovered to be broken. I have been bringing her to different vets for over a year about why she goes into a panting mode for awhile. They did every test all negative but recent x-rays showed broken pin and arthritis and Cruciate Ligament damage. She was already on Rimidol for many months and now they have added Tramidol for pain and now the fetinal patch is added. She now wimpers when I leave the room and when she starts to pant it goes on strong for about 4 hours then it stops.I'm starting to think the Rimadol should be stopped so I didn't give it to her today. She is going to have surgery to repair the Cruciate Ligament on Tuesday but now the other left is damaged as well and it is worse then the first one. Does anyone have any information to help my bully? Thanks, Kathy Morrow

My little 7 year old maltese Romeo is currently fighting for his life as a result of DERAMAXX. He was a perfectly healthy dog until my Vet prescribed him Deramaxx with NO WARNING OR PRECAUTION AS TO POSSIBLE SIDE EFFECTS. Romeo had to get minor surgery on Monday 03/15/10 to remove a stone in his bladder and was prescribed DERAMEXX. Picked Romeo up on Tuesday and he was his usual self despite having stitches-running around, licking me, eating and drinking normal. Two days after the surgery he was unable to walk, constant shivers, refusing to eat or drink water and no eye movement. We rushed him to our vet and they told us they wanted to keep him overnight to observe him…we recieved a call at 9am the next day informing us that Romeo had a siezure at 1am in the morning and was unresponsive!!!!

We rushed him to animal hospital in Manhattan…the vets are trying to tell me its unlikely its due to the DERAMAXX but an underlying issue with his LIVER. $6,000 later AND a broken heart and he is still in ICU with NO TRUTHFUL ANSWERS AS TO WHAT REALLY CAUSED MY HEALTHY ROMEO TO LAY IN A COMA IN ICU!